PresbyopiaNCT04189224

Evaluation of a Reusable Silicone Hydrogel Multifocal Contact Lens

A study testing JJV Investigational Multifocal Contact Lens and 1-Day Acuvue® Moist Brand Multifocal Contact Lens in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a randomized, single-masked, crossover clinical trial. There are two study lenses. Each lens will be dispensed for 3 ± 1 days and then an optimization visit will occur. The final lens pair will be dispensed for 12 ± 2 days and the follow-up on the final lens pair will occur. Read more about this study

Who is it for?: Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Presbyopia
What is being tested?: JJV Investigational Multifocal Contact Lens and 1-Day Acuvue® Moist Brand Multifocal Contact Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 4 sitesUnited States
Study dates: 15 Nov 2019to 10 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be at least 40 years of age and not greater than 70 years of age at the time of consent.
Subjects must own a wearable pair of spectacles if required for their distance vision.
The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration).

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The subject must either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" (Appendix E).
The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D in each eye.
The subject's refractive cylinder must be ≤0.75 D in each eye.
The subject's ADD power must be in the range of +0.75 D to +2.50 D.
The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye.

Who cannot join

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Currently pregnant or lactating.
Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens- Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
A history of amblyopia, strabismus or binocular vision abnormality.

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Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, oral phenothiazines, oral/topical/inhaled anticholinergics, systemic/topical corticosteroids.
Use of any ocular medication, with the exception of rewetting drops.
History of herpetic keratitis.
History of irregular cornea.
History of pathological dry eye.
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
Any known hypersensitivity or allergic reaction to Optifree®Replenish® multipurpose care solution, sodium fluorescein or non-preserved rewetting drop solutions.
Clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions.
Any current ocular infection or inflammation.
Any current ocular abnormality that may interfere with contact lens wear.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

ProCare Vision Centers
Granville, Ohio, 43023
Frazier Vision Inc.
Jacksonville, Texas, 75703
Maitland Vision Center
Maitland, Florida, 32751
Advanced Eyecare
Raytown, Missouri, 64133

Other trials in United States

About this study

Official title: Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase II

Conditions: Presbyopia
Being tested: JJV Investigational Multifocal Contact Lens, 1-Day Acuvue® Moist Brand Multifocal Contact Lens
Medical subject headings: Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JJV Investigational Multifocal Contact LensDevice
TEST
1-Day Acuvue® Moist Brand Multifocal Contact LensDevice
CONTROL

Study groups in NCT04189224
Study group	Role	What they receive
Test/Control	Experimental	Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized to sequence, Test/Control. Receives: Device: JJV Investigational Multifocal Contact Lens; Device: 1-Day Acuvue® Moist Brand Multifocal Contact Lens
Control/Test	Experimental	Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized to sequence, Control/Test. Receives: Device: JJV Investigational Multifocal Contact Lens; Device: 1-Day Acuvue® Moist Brand Multifocal Contact Lens

What is being measured

The primary outcome is the main question the study is designed to answer.

Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Measured: 2-Week Follow-up
Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Measured: 2-Week Follow-up
Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Measured: 2-Week Follow-up

Secondary outcomes (4)

Overall Vision Scores
Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, aged 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Measured: 2-Week Follow-up
Overall Comfort Scores
Overall comfort scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, aged 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Measured: 2-Week Follow-up
Number of Grade 3 or Higher Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). Slit Lamp Findings were assessed at the 2-Week Follow-up. SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The number of eyes with SLF with grade 3 or higher by lens was reported.
Measured: 2-Week Follow-up
Proportion of Subjects That Reported Ocular Symptoms
Subject reported ocular symptoms were assessed using a questionnaire at the 2-week follow-up. Subjects were asked if they experienced any of the following symptoms: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other; using the scale of: None, Mild, Moderate and Severe. The proportion of subjects that reported symptoms (Mild, Moderate and Severe) was reported for each lens type.
Measured: 2-Week Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 201910 Mar 2020

First posted6 Dec 2019
Study start15 Nov 2019
Primary completion10 Mar 2020
Study completion10 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PresbyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04189224
Sponsor's protocol ID: CR-6372
Status last verified: Apr 2025
First submitted: 4 Dec 2019
Last updated: 27 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase II
ClinicalTrials.gov ID: NCT04189224
Acronym / sponsor ID: CR-6372
Conditions: Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 15 Nov 2019 (actual)
Primary completion: 10 Mar 2020 (actual)
Study completion: 10 Mar 2020 (actual)
First posted: 6 Dec 2019 (actual)
Results: Posted 2 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Test/Control	Experimental	Device: JJV Investigational Multifocal Contact Lens, Device: 1-Day Acuvue® Moist Brand Multifocal Contact LensHyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized to sequence, Test/Control.
Control/Test	Experimental	Device: JJV Investigational Multifocal Contact Lens, Device: 1-Day Acuvue® Moist Brand Multifocal Contact LensHyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized to sequence, Control/Test.

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

Key exclusion criteria (18 listed)

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JJV Investigational Multifocal Contact LensTEST	Device	Control/Test, Test/Control
1-Day Acuvue® Moist Brand Multifocal Contact LensCONTROL	Device	Control/Test, Test/Control

Primary outcome

Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright
Time frame: 2-Week Follow-up
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles
Time frame: 2-Week Follow-up
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright
Time frame: 2-Week Follow-up
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.

4 secondary outcomes

Overall Vision Scores
Time frame: 2-Week Follow-up
Overall Comfort Scores
Time frame: 2-Week Follow-up
Number of Grade 3 or Higher Slit Lamp Findings
Time frame: 2-Week Follow-up
Proportion of Subjects That Reported Ocular Symptoms
Time frame: 2-Week Follow-up

Results and safety

Results posted to the registry on 2 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test/Control	23	23
Control/Test	21	21

Primary outcome: Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright

Time frame: 2-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Test (Senofilcon A) n = 40	Control (Etafilcon A) n = 40
Standard High Contrast Bright: Distance	-0.12 (0.073)	-0.12 (0.067)
Standard High Contrast Bright: Intermediate	-0.06 (0.070)	-0.06 (0.072)
Standard High Contrast Bright: Near	0.07 (0.097)	0.08 (0.106)

Population analysed: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.

Primary outcome: Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles

Time frame: 2-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Test (Senofilcon A) n = 40	Control (Etafilcon A) n = 40
Standard High Contrast Dim with Goggles: Distance	0.14 (0.109)	0.13 (0.085)
Standard High Contrast Dim with Goggles: Intermediate	0.02 (0.095)	0.00 (0.091)
Standard High Contrast Dim with Goggles: Near	0.18 (0.098)	0.16 (0.101)

Population analysed: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.

Primary outcome: Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright

Time frame: 2-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Test (Senofilcon A) n = 40	Control (Etafilcon A) n = 40
Standard Low Contrast Bright: Distance	0.08 (0.093)	0.07 (0.075)
Standard Low Contrast Bright: Intermediate	0.12 (0.075)	0.10 (0.094)
Standard Low Contrast Bright: Near	0.25 (0.113)	0.27 (0.119)

Population analysed: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the duration of the study. Approximately 21-28 days per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test	0 of 44 (0%)	0 of 44 (0%)	0 of 44
Control	0 of 44 (0%)	0 of 44 (0%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Related trials for Presbyopia

Recruiting
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Clinical Trial With Artiflex Presbyopic (Artiplus)
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright (time frame: 2-Week Follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04189224.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.